Ordering Caris Molecular Profiling: The process from start to finish

Home / Ordering Caris Molecular Profiling: The process from start to finish

The information on this page is designed to help you know what to expect when you order tumour profiling.

 

1.      Your oncologist contacts Precision Oncology to order the test

The first step in the tumour molecular profiling process is for your doctor to order the test. Only an oncologist can order these tests. Most people hear about tumour molecular profiling and how it can personalise their cancer treatment from their oncologist.

If you have heard about the benefits of tumour profiling and are interested in ordering the tests, speak to your oncologist.

This brochure discusses how Caris Molecular Intelligence is used to provide actionable treatment options. You may print this brochure and take it to your next appointment to discuss with your oncologist.

 

 

When you and your oncologist decide to have your cancer tumour profiled, your oncologist must send a requisition form to Precision Oncology via email. Precision Oncology is the exclusive Australian and New Zealand distributor for Caris Molecular Intelligence, the organisation that performs tumour profiling in their state of the art, specialised laboratory in the US.

What is molecular profiling?

A molecular profile reveals unique characteristics of a person’s disease at the molecular level, providing doctors with knowledge about which treatments are most likely to produce the best results, including treatments that may not have been previously considered. Molecular profiling may also help patients avoid treatments that are ineffective, unnecessary, and potentially harmful.1

Where does the sample for profiling come from?

A sample of your tumour will be removed by a biopsy procedure. Depending on where the tumour is located, this may be done under local or general anaesthetic. The entire tumour may be removed (called an excisional biopsy) or a small part of a large tumour may be removed (called incisional biopsy).2

After removal, the tissue is preserved in a solution of water and a preservative (usually formaldehyde, also called formalin). The tissue and preservative are placed in a container, and labelled with your name and details of the body site the tissue came from. It is sent to a pathology laboratory for testing.3

Pathologists use a range of techniques to examine the tissue, including looking at the entire tissue sample with the naked eye (known as gross examination) and looking at the tissue under a microscope (known as microscopic examination).3

Before tumour tissue can be examined under a microscope, it needs to be hardened so that it can be cut into thin slices. Your tumour tissue will probably be embedded with paraffin wax to harden it before it is cut into sections.4 This produces a ‘permanent section’4 which can be stored after examination and re-examined if necessary.2

Any preserved tissue remaining after pathology tests have been performed is stored at the pathology laboratory, typically for 2-10 years. Storing tissue is a requirement for accredited laboratories.5 It ensures that the tissue is available for re-examination if you want to get a second opinion on your diagnosis. The tissue can also be used for further testing (including molecular profiling). If you experience a cancer recurrence, stored tissue from a previously treated tumour can be compared to tissue from the new tumour to guide treatment.3 However, freezing, storing and thawing tissue samples can influence the quality of the sample.6

2.      Precision Oncology contacts the patient for consent and payment

When Precision Oncology receives the requisition form from your oncologist, they will contact you to obtain your consent to analyse your tissue sample and organise payment for the service.

Precision Oncology will send you a consent form, or you can download it from the website. The consent form explains what information will be sent to Caris Molecular Intelligence with your tumour sample. It also explains the steps Caris will take to ensure your information is protected, including the results of any tests performed. The consent form also contains information about how your personal information might be used, and what will happen to your tumour sample.

You will be asked to read the consent form, and print your name and date and sign the form on the second page. You can then scan and email it to Precision Oncology, or take a photo of it and email the photo. You need to do this as soon as possible, as molecular profiling cannot commence until you have provided your consent.

You will be asked to make a payment of $9,600 (Australian) via direct transfer or credit card using the secure online facility on the Precision Oncology website. We will provide direct transfer details via email.

3.      Precision Oncology organises your sample and paperwork

Precision Oncology will compile relevant paperwork including your pathology report. This contains information about your tumour that the pathologist discovered during the examination. A pathology report usually includes:4

  • Your personal information, including name and birth date.
  • Findings of the gross examination, including size (if the sample is an entire tumour), shape and consistency of the tumour tissue.
  • Findings of the microscopic examination, particularly any abnormal features of the tumour cells.
  • Diagnosis, which includes the site and stage of cancer.
  • Information on forthcoming tests, if the tumour tissue has been sent for additional testing.

Your pathology report is usually available within ten days of your biopsy being taken.4

Precision Oncology will also check that the laboratory has an appropriate specimen (for example, one that is large and recent enough). Usually you will not need to have a new tumour sample taken and an existing sample stored at the pathology laboratory will be used. However, if the existing specimen is too old or not appropriate, your physician may ask you to have another biopsy. Sending an appropriate specimen is vital to ensure best results.

4.      The tumour sample is sent to the Caris lab

Caris lab

Precision Oncology will organise for the tumour sample and related paperwork, including your medical information, to be sent to the Caris laboratory. The tumour specimen is packed in a cooled shipping kit and sent by priority FedEx courier for maximum efficiency. Precision Oncology tracks every sample and will let you know when it has arrived.

5.      Caris establishes your case

Caris will establish your case as soon as they receive the tissue specimen. This involves compiling your personal and medical information in a computer database. Your test results will be added to your case after the tests have been performed.

6.      Molecular profiling is conducted in the Caris Molecular Intelligence laboratory

Caris can then start testing your tumour for cancer biomarkers. The multiplatform profiling tests performed by Caris examine a comprehensive range of cancer biomarkers, including:

  • Proteins: Molecules that regulate the structure and function of body tissues.7
  • RNA: Strands of nucleotides which regulate body processes, including the formation of new proteins in cells.8
  • Genes (DNA): Particularly mutations in the DNA which are associated with an increased risk of cancer.9
  • Antibodies and antigens: Components of the immune system and foreign substances that the immune system responds to, respectively.10

A series of extensive and scientifically advanced tests will be performed on your tumour specimen including:11

  • Immunohistochemistry (IHC):Determines the level of protein expression.
  • in situhybridization: Detects gene deletions, amplifications, translocations and fusions.
  • Next-Generation Sequencing (NGS):Rapidly examines and more broadly detects DNA mutations, copy number variations and gene fusions across the genome.
  • Sanger Sequencing:Examines strands of DNA to identify mutations by analysing long contiguous sequencing reads.
  • Pyro Sequencing (PyroSeq):Detects and quantifies mutations and methylation through sequencing by synthesis.
  • Fragment Analysis (FA):Detects changes in DNA or RNA to indicate the presence or absence of genetic markers.

For more information, see the brochure on tumour profiling services.

During the testing process, Precision Oncology will monitor the progress of profiling using an internet portal which tracks your tumour specimen and the tests that have been performed on it. Precision Oncology will tell you when the report is likely to be with your oncologist so you can make an appointment to discuss your best treatment as soon as the report is ready.

The results of the tests are analysed by a multidisciplinary group of scientists (including medical doctors, research doctors, pathologists and oncologists) in the Caris laboratory. The Caris Molecular Intelligence Report is then compiled, outlining the results of the tests and providing information about cancer therapies which are and are not likely to be of benefit to you, based on the results of the tests. The report also includes information about clinical trials of new drugs being tested as cancer therapies that you may be eligible to enrol in, based on the profile of your cancer.

Your tumour sample is then returned to the pathology lab in Australia or New Zealand within 6 weeks of testing.

7.      Precision Oncology sends the final report to your oncologist

Caris Molecular Intelligence sends the Molecular Intelligence Report directly to your oncologist as soon as it is ready. This is usually within 14 days of your specimen being received at the Caris laboratory. Your physician can talk with a physician at the Caris laboratory if they have any questions or require more information about any information contained in the Molecular Intelligence Report.

8.      Your oncologist will institute evidence-based, personalised cancer therapy

Your oncologist will discuss the results of the tests and your treatment options with you. The information contained in the report enables your physician to personalise your cancer therapy, choosing medicines that have proven effective in treating cancers with similar biomarkers and avoiding treatments which are unlikely to be effective. Receiving the treatments that will work best for you means you will be avoiding ineffective treatments, saving time and unnecessary exposure to their side effects.

 

References

  1. Caris Life Sciences. Exploring new options: What is precision medicine? 2017 (cited 16 July 2017). Available from: [URL link]
  2. American Cancer Society. Types of biopsies used to look for cancer. 2015 (cited 21 May 2017). Available from: [URL link]
  3. American Cancer Society. What happens to biopsy and cytological specimens? 2015 (cited 5 March 2017). Available from: [URL link]
  4. National Cancer Institute. Pathology reports. 2010 (cited 5 March 2017). Available from: [URL link]
  5. Australian Government Department of Health. Pathology –The Facts –What should I know about pathology test results? 2013 (cited 2 June 2017). Available from: [URL link]
  6. Shabihkhani M, Lucey GM, Wei B, et al. The procurement, storage, and quality assurance of frozen blood and tissue biospecimens in pathology, biorepository, and biobank settings. Clin Biochem. 2014;47(4-5):258-66. [Full text]
  7. Genetics Home Reference. What are proteins and what do they do? 2017 (cited 14 May 2017). Available from: [URL link]
  8. Nature Education. Ribonucleic acid/RNA. 2014 (cited 2 June 2017). Available from: [URL link]
  9. Muller PAJ, Vousden KH. Mutant p53 in cancer: New functions and therapeutic opportunities. Cancer Cell. 2014; 25(3): 304-17. [Full text]
  10. National Cancer Institute. NCI dictionary of cancer terms: Antibody. 2011 (cited 2 June 2017). Available from: [URL link]
  11. Caris Life Sciences. CMI overview. 2017 (cited 21 June 2017). Available from: [URL link]
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